Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant
If subjects are listed for kidney transplant and are considered sensitized, this means they have a high amount of antibodies in their blood that could react to a kidney transplant offered for them. Antibodies are protein substances made by the body that fight anything that the body considers as a threat to it, such as infection or a kidney transplant. Sensitization may be due to prior transplants, pregnancy, or blood transfusions. Being sensitized can increase the subject's kidney transplant waiting time as it is more difficult to find a suitable kidney transplant for them that their antibodies will not react to. The purpose of this research study is to see if giving the investigational drug belimumab up to one year pre-transplant can de-sensitize the subjects, or decrease the amount of antibodies in their blood. This may help make the subjects eligible to receive a kidney transplant more quickly. If after receiving belimumab, the subjects are compatible with a donor kidney offered and are medically suitable for transplant at that time, a kidney transplant will be performed.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||One Year Exploratory Study to Evaluate the Efficacy and Safety of Belimumab for Normalization of Alloantibody Levels in Sensitized Patients Awaiting Kidney Transplantation|
- To assess the effectiveness of belimumab for decreasing antibody levels in sensitized patients awaiting kidney transplantation. [ Time Frame: up to one year pre-transplant ] [ Designated as safety issue: No ]
- To determine whether reduction in antibody levels by belimumab therapy permits subsequent successful kidney transplantation from a cross-match compatible donor. [ Time Frame: up to one year pre-transplant ] [ Designated as safety issue: No ]
- To describe the pharmacokinetics of belimumab in sensitized patients awaiting kidney transplantation. [ Time Frame: up to one year pre-transplant ] [ Designated as safety issue: Yes ]
- To assess the safety of belimumab in sensitized patients awaiting kidney transplant [ Time Frame: up to one year pre-transplant ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||January 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).
The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant.
Approximately one third of patients awaiting kidney transplant at our transplant center have significant levels of antibodies in their blood leading to a longer wait time for a kidney transplant and death. Antibodies in the blood may be due to prior transplants, pregnancy, or blood transfusions. These antibodies sensitize a patient and make it more difficult for the patient to get a compatible kidney transplant. The measure of these antibodies is called panel reactive antibodies (PRA) and can range from 0-100%, with 100% being most sensitized. The waiting time for patients with a PRA in the range of 20%-79% is over 5 years as compared to patients with low PRA (0%-19%) which is 3-4 years. Patients with a PRA greater than 80% are likely to be granted extra points to increase the chances of transplantation. Antibodies in these patients may be due to prior transplants, pregnancy, or blood transfusions. To date, no trials with belimumab have been performed in patients with pre-existing antibodies awaiting kidney transplantation. This study is undertaken to assess the effectiveness and safety of using belimumab to normalize antibody levels in sensitized patients awaiting kidney transplantation. It is hoped that decreasing these antibodies will decrease the waiting time on the kidney transplant list, and allow the patient to become compatible with a donor kidney for transplant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025193
|United States, Pennsylvania|
|University of Pennsyvlania Kidney Transplant Program|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ali Naji, MD, Ph D||University of Pennsylvania|